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Recall Observatory FDA recall evidence

Device product

Revolution CT

Z-2004-2021

March 19, 2021

Class II

Product summary

Firm
GE Healthcare, LLC
Event
Event 88150
Status
Completed
Classification
Class II
Quantity
197 (US = 40; OUS = 157)
Official record key
device-enforcement:Z-2004-2021

Official wording

Reason: GE Healthcare has become aware of a potential issue on the Revolution CT system where a collimator blade does not find its appropriate home position. This issue could result in the delivered dose of x-ray radiation being either larger or smaller than its prescribed value.

Code information: 5590000 5590000-6 5590000-2

Distribution pattern: Worldwide distribution - US Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    GE Healthcare has become aware of a potential issue on the Revolution CT system where a collimator blade does not find its appropriate home position. This issue could result in the delivered dose of x-ray radiation being either larger or smaller than its prescribed value.